NOTE: The policies, guidelines, terms, and conditions
stated in this announcement may differ from those used by the NIH. Where
this Funding Opportunity Announcement (FOA) provides specific written
guidance that may differ from the general guidance provided in the grant application
form, please follow the instructions given in this FOA. Also note that AHRQ may
have different page limits than NIH for the application Research Strategy,
which can be found within each individual FOA (see Section IV below). AHRQ
Grants Policy and Information to applicants regarding Funding Opportunity
Announcement procedures can be found at Funding Opportunity
Announcement Guidance.

This funding opportunity announcement (FOA) solicits Small
Research (R03) grant applications from organizations that propose to analyze
and describe the costs associated with successful efforts to transform
primary care practice.

Key Dates

Posted Date

December 18, 2012

Open Date (Earliest Submission Date)

January 28, 2013

Letter of Intent Due Date(s)

January 28, 2013

Application Due Date(s)

February 28, 2013, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date

Expiration Date

March 1, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions.

Applications that do not comply with these
instructions may be delayed or not accepted for review.

This funding opportunity announcement (FOA) solicits Small
Research (R03) grant applications from organizations that propose to analyze
and describe the costs associated with successful efforts to transform primary
care practice.

Background:

Revitalizing the Nation’s primary care system is
foundational to achieving high-quality, accessible, efficient health care for
all Americans. The primary care medical home, also referred to as the patient
centered medical home (PCMH), advanced primary care, and the healthcare home,
is one promising model for transforming the organization and delivery of
primary care. AHRQ had defined the PCMH as a model of the organization of
primary care that delivers the core functions of primary health care
encompassing five functions and attributes: patient-centered, comprehensive,
coordinated, accessible care, and a system-wide focus on quality and safety. A
great deal of quality improvement, experimentation, demonstration, and research
is currently being conducted around this model and other similar frameworks to
improve the delivery of primary care. To date, much of the evaluation of this
work has focused on the success of improving quality outcomes. Additional
critical work has focused on increasing understanding of how best to implement
and sustain primary care practice change. This includes AHRQ’s 2010 R18 RFA
“Transforming Primary Care Practice”. To date, however, less attention has been
given to exploring the costs associated with supporting and maintaining
systematic redesign of primary care practice.

Knowledge
to be achieved:

With this announcement, AHRQ is interested in adding knowledge
about the direct and indirect costs associated with supporting primary care
transformation. While proposed projects may utilize the methods of
cost-benefit, cost-effectiveness, or cost-utility analyses on the support and
maintenance of primary care transformation, given the dearth of current valid
information available, AHRQ also is interested in receiving proposals to
document the direct and indirect financial costs shouldered by small and medium
sized practices in becoming a patient centered medical home and the direct and
indirect external costs involved in successful primary care practice
facilitation programs.

Specific
Objectives of this FOA:

The objective of this initiative is to be able to provide
stakeholders, including independent primary care practices, health care
systems, health care payers, and other health care system decision makers with
information about the costs of transformative, system-level primary care
practice redesign and implementation.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon AHRQ
appropriations and the submission of a sufficient number of meritorious
applications.

AHRQ intends to fund approximately 12 awards,
corresponding to a total of $1,200,000 for fiscal year 2013.

Award Budget

The total costs (direct and indirect) for a project awarded
under this FOA will not exceed $100,000 for the entire project period.

Award Project Period

The project period may not
exceed 18 months.

These projects are being funded pursuant to 42 U.S.C. 299a,
which provides that AHRQ shall conduct and support research, support
demonstration projects, and disseminate information on health care and on
systems for the delivery of such care, including activities with respect to the
quality, effectiveness, efficiency, appropriateness, and value of health care
services.

You may submit an application(s) if your
institution/organization has any of the following characteristics:

Public or
non-profit private institution, such as a university, college, or a faith-based
or community-based organization;

Units of
local or State government;

Eligible
agencies of the Federal government.

Indian/Native
American Tribal Government (Federally recognized)

Indian/Native
American Tribal Government (Other than Federally recognized);

Indian/Native
American Tribally Designated Organizations.

AHRQ’s authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research
mechanism, thus AHRQ will make grants only to non-profit organizations.
For-profit organizations may participate in projects as members of consortia or
as subcontractors only. Because the purpose of this program is to improve
healthcare in the United States, foreign institutions may participate in
projects as members of consortia or as subcontractors only. Applications
submitted by for-profit organizations or foreign institutions will not be
reviewed. Organizations described in section 501(c) 4 of the Internal
Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform
a substantive role in the conduct of the planned project or program activity
and not merely serve as a conduit of funds to another party or parties. If
consortium/contractual activities represent a significant portion of the
overall project, the applicant must justify why the applicant organization,
rather than the party(s) performing this portion of the overall project, should
be the grantee and what substantive role the applicant organization will play.
Justification can be provided in the Specific Aims or Research Strategy section
of the PHS398 Research Plan Component sections of the SF424 (R&R) application.
There is no budget allocation guideline for determining substantial
involvement; determination of substantial involvement is based on a review of
the primary project activities for which grant support is provided and the
organization(s) that will be performing those activities.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for AHRQ support.
Only one PD/PI may be designated on the application.

2. Cost Sharing

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this
FOA, AHRQ welcomes applicant institutions, including any collaborating
institutions, to devote resources to this effort. An indication of
institutional support from the applicant and its collaborators indicates a
greater potential of success and sustainability of the project. Examples of
institutional support would include: donated equipment and space, institutional
funded staff time and effort, or other resource investments. Applicant institutions
should indicate institutional support by outlining the specific contributions
to the project and providing assurances that their organization and any
collaborators are committed to providing these funds and resources to the
project. This information can be included at the end of the budget
justification section of the application, but institutional support dollars are
not to be shown/included in the detailed budget request.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

AHRQ will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months, except for
submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows AHRQ staff to estimate the potential review workload
and plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive title of proposed research

Name(s), address(es), and telephone number(s) of the PD/PI

Names of other key personnel

Participating institution(s)

Number and title of this funding opportunity

The letter of intent can be sent electronically, and should
be sent to:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Budget
Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding
from AHRQ should ignore application instructions concerning the Modular Grant
Application and Award Process, and prepare applications using instructions for
the Research and Related Budget Components of the SF 424 (R&R).
Applications submitted in the Modular format will not be reviewed.

PHS 398 Research Plan Component

All application instructions outlined in the SF424 (R&R)
Application Guide that
are not otherwise specified within this Funding Opportunity Announcement must
be followed, incorporating "Just-in-Time" information concepts, and
with the following additional requirements:

Specific Aims is limited to 1 page.

Research Strategy, including tables, graphs, figures, diagrams,
and charts, is limited to 6
pages.

Research
Strategy Section:

Section I: Practice Transformation Overview

The research section should begin with a section
describing the group of primary care practices involved in the study and
demonstrating that the practices have successfully undergone a practice-level
transformation in how they deliver primary care services that resulted in
documented improvements in quality. This section must be two-pages or less in
length.

All practices selected for the study must be
dedicated to the provision of primary care as defined by the IOM: “the
provision of integrated, accessible health care services by clinicians who are
accountable for addressing a large majority of personal health care needs,
developing a sustained partnership with patients, and practicing in the context
of family and community.” (IOM, 1996)

While AHRQ is not specifying a minimum number of
practices that must be included in the study, reviewers will be considering the
number of practices in their evaluation of proposals. AHRQ is
particularly interested about the costs associated with primary are
transformation in small and medium (practice of 10 and fewer lead providers) as
less information is available on them. AHRQ also is interested in developing
the evidence base around costs for practices that serve minority populations
and underserved communities.

Applications must demonstrate that the practices to
be studied have undergone a significant change in the organization and delivery
of primary care. Such efforts must clearly have gone beyond incremental
quality improvement activities and be aimed towards whole practice redesign
that involves the replacing of old processes of care delivery with new
ones. Practices must have engaged in a comprehensive set of
practice-level changes as:

new
arrangements for patient scheduling and access/outreach

new
strategies for patient engagement, such as group visits

development
of team-based care and cross-trained staff

new
methods of bringing current evidence to the point of care and managing
population health

interventions
to encourage patient and family involvement and shared decision-making

new
methods of coordinating care with other parts of the health care system and
with community resources

new
methods of measuring and improving quality and safety

innovations
in practice management

new uses
of information systems and technology

Projects that aim to study practices whose efforts
have focused solely on one quality improvement component, such as health IT
implementation alone, are not eligible for this funding opportunity.

In the opening section, applicants must describe the
characteristics of transformation achieved by the practices being studied.

To the extent possible, applications should also
describe what is already known about the outcomes of the primary care transformation
effort. This may include improvement in process measures and/or external PCMH
recognition such as through NCQA or URAC. Demonstration of improvements in
quality outcomes, including health outcomes, health care utilization, and
patient experience will make information about cost more valuable to
stakeholders and will strengthen proposals. Information about the effect of
transformation on team functioning and staff experience also should be
described if available.

Section II: Cost Analysis Plan

The next section of the research plan must describe
the specific cost analysis plan. This section must also address the data
collection, potential challenges and proposed solutions, study limitations, and
the usefulness of the study results to stakeholders. This section is limited
to no more than four pages.

AHRQ has specific interest in proposals that will
provide information on the direct and indirect costs of primary care practice
transformation for the individual primary care practice. Applications may also
focus on the direct and indirect costs to health care systems in which primary
care practices are embedded or costs to external practice facilitation
providers. While of interest, given the size of these grant awards, AHRQ does
not expect proposals to address larger comprehensive assessments of societal
costs.

Applications should also differentiate between costs
associated with practice transformation and costs associated with on-going
maintenance of change. It is not required that proposals address both of these
types of costs, but proposals must clearly define what types of cost they are
describing.

Applications should describe what if any financial
and non-financial incentives were available to practices for primary care
transformation and how any such incentives will be included in the cost
analysis.

Applications should consider carefully how costs associated
with health IT implementation will or will not be included in their analysis.
AHRQ recognizes that while health IT can be a powerful tool for primary care
transformation and implementation of a PCMH, health IT can be implemented
without greater attention to primary care practice redesign. Proposals must
explain why or why not the direct and indirect costs of health IT
implementation will be included in the analyses and how federal health IT
incentives will or will not be included in cost analysis.

Given the above requirements and limitations in time
frame and funding, AHRQ expects and encourages proposals to build upon previous
evaluation efforts. While applications building upon foundational work funded
by AHRQ, including expansions of work begun through AHRQ’s “Transforming
Primary Care Practice” FOA are encouraged, it is not required that previous
work have been funded by AHRQ. Applications expanding upon prior work need to describe
the data sets to be used, discuss the completeness, reliability and accuracy of
the data, and demonstrate that the proposed analysis is distinct from
previously conducted activities. If new data collection is proposed, in
addition to describing how it will be conducted, applicants must demonstrate
how it will be conducted within the time frame and budget of the proposed
study.

Section III: Research Team

The third section of the research plan must describe
the capabilities and experience of the research team. In addition to
significant expertise in primary care and complex health system implementation
evaluation, the study team should include experts in economics and cost
evaluation. This section should not be more than one page in length and may be
shorter.

Section IV: Dissemination

The fourth and final section of the research plan must
describe a dissemination plan. An extensive dissemination plan is not
required. The applicant should ensure that all project findings are shared
with AHRQ and should describe plans for development and submission of at least
one peer—reviewed manuscript or other appropriate vehicle for sharing results
with key stakeholders. This section should not be more than one page in
length.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide, with the following modification:

An appendix may be used to provide additional information on the
primary care practices to be studied, the primary care transformation
initiative that has already been conducted, and/or the details of prior
evaluations. This material should supplement and not entirely replace
discussion in the body of the research plan. This appendix may not be greater
than 6 pages in length.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For efficient grant administration, AHRQ grant administration
procedures will be used and conducted in accordance with the terms and
conditions, cost principles, and other considerations described in the HHS
Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own
risk and without AHRQ prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs are necessary to conduct the project and
would be allowable under the grant, if awarded, without AHRQ prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain AHRQ approval before incurring the cost. AHRQ prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:The PD/PI must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to AHRQ.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH, and for responsiveness by
AHRQ. Applications that are incomplete and/or nonresponsive will not be
reviewed.

In order to expedite the review, applicants are requested to
notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and
title, PD/PI name, and title of the application.

Although there is no immediate acknowledgement of the
receipt of an application, applicants are generally notified of the review and
funding assignment within eight (8) weeks.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending
the Public Health Service Act, directed AHRQ, in carrying out its mission, to
conduct and support research and evaluations, and to support demonstration
projects, with respect to the delivery of health care in inner-city and rural
areas (including frontier areas), and health care for priority populations.
Priority populations include low income groups; minority groups; women;
children; the elderly; and individuals with special health care needs,
including individuals with disabilities and individuals who need chronic care
or end-of-life health care. This authority is found at 42 USC 299(c). Women
and members of minority groups are included in all AHRQ-supported research
projects involving human subjects, unless a clear and compelling rationale and
justification is provided that inclusion is inappropriate, e.g. because of the
lack of connection between the study and the health of women or particular
minorities. Investigators should review the February 2003 policy entitled,
“AHRQ Policy on the Inclusion of Priority Populations,” which is available at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing; the format of the final
dataset; the documentation to be provided; whether or not any analytic tools
also will be provided; whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use); and the mode of data sharing (e.g., under its own
auspices by mailing a disk or posting data on its institutional or personal
website or through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.

The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires
that information that is obtained in the course of AHRQ supported activities
and that identifies individuals or establishments be used only for the purpose
for which it was supplied. Information that is obtained in the course of
AHRQ-supported activities and that identifies an individual may be published or
released only with the consent of the individual who supplied the information
or is described in it. There are civil monetary penalties for violation of the
confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human
Subjects section of the application, applicants must describe procedures for
ensuring the confidentiality of the identifying information to be collected.
The description of the procedures should include a discussion of who will be
permitted access to this information, both raw data and machine readable files,
and how personal identifiers and other identifying or identifiable data will be
restricted and safeguarded. Identifiable patient health information collected
by grantees under this FOA will also be obtained and managed in accordance with
the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containing
confidential data have a level and scope of security that equals or exceeds
that established by the HIPAA Security Rules if applicable (see HIPAA website
in prior paragraph) and that established by the Office of Management and Budget
(OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated
Information Systems. The applicability and intended means of applying these
confidentiality and security standards to subcontractors and vendors, if any,
should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may
copyright, or seek patents for, as appropriate, final and interim products and
materials developed in whole or in part with AHRQ support, including, but not
limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce,
publish, use or disseminate for any purpose consistent with AHRQ’s statutory
responsibilities and to authorize others to do so for any purpose consistent
with AHRQ’s statutory responsibilities. In accordance with its legislative
dissemination mandate, AHRQ purposes may include, subject to statutory
confidentiality protections, making project materials, databases, results, and
algorithms available for verification or replication by other researchers. In
addition, subject to AHRQ budget constraints, final products may be made
available to the health care community and the public by AHRQ or its agents if
such distribution would significantly increase access to a product and thereby
produce substantial or valuable public health benefits. Ordinarily, to
accomplish distribution, AHRQ publicizes research findings but relies on
grantees to publish research results in peer-reviewed journals and to market grant-supported
products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes
to be consulted in advance of publication in order to coordinate announcements
of new AHRQ-supported research results with other AHRQ dissemination
activities. Important legal rights and requirements applicable to AHRQ
grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part
67, Subpart A (available in libraries and from the GPO's website at
http://www.gpoaccess.gov/cfr/index.html) which incorporates additional
applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR
Part 401.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

The mission of AHRQ is to improve the quality, safety,
efficiency, and effectiveness of health care for all Americans. As part of this
mission, applications submitted to AHRQ to support health services research are
evaluated for scientific and technical merit through the AHRQ peer review
system.

Applications that are complete and responsive to the FOA
will be evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with standard AHRQ peer review procedures
that are described in 42 CFR Part 67, Subpart A. Incomplete and/or
non-responsive applications or applications not following instructions given in
this FOA will not be reviewed.

The R03 small grant supports discrete, well-defined projects
that realistically can be completed in one year to 18 months and that require
limited levels of funding. Because the research project usually is limited, an
R03 grant application may not contain extensive detail or discussion.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed and assigned a priority score

Receive a written critique

Administrative Criteria: Upon receipt, applications will be
evaluated for completeness by the Center for Scientific Review, NIH, and
reviewed for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described
below, will be considered in the review process.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does this study add to the understanding of the costs
associated with primary care transformation? If the aims of the application
are achieved, will primary care practices and health system policy makers and
implementers find the results meaningful and useful?

Investigator(s)

Are the PD/PI and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level(s) of the principal investigator(s) and
other researchers? Do the PD/PI and investigative team bring complementary and
integrated expertise to the project (if applicable)? Does the team have the
necessary skills and experience in cost accounting, cost effectiveness, and
economics to successfully conduct the proposed work?

Innovation

Does the project add to the understanding of the
costs associated with primary care practice transformation? Does the project
examine a selection of practices that represent an understudied part of the health
care system, such as practices that serve minority or underserved communities?
Does the project develop or employ novel concepts, approaches or methodologies,
tools, or technologies for this area?

Approach

Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, well-reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? Will the team be able to
complete the study with the proposed budget and within the proposed time frame?

Environment

Do(es) the scientific environment(s) in which the
work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment(s), or
subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Degree of Responsiveness

Reviewers will assess how well the application
addresses the purpose and objectives of this FOA. Reviewers will assess how
responsive the application is to the special eligibility criteria, including
the project requirements, noted in the FOA. []

The committee will evaluate whether the proposed
budget is reasonable and whether the requested period of support appropriate in
relation to the proposed research.

Privacy and Security Protections for
Patients

Reviewers will assess the resources and processes to
be used to address privacy and security issues in the development and
implementation of the intervention will be assessed. (Note: use this as
appropriate)

Additional Review Considerations

Not Applicable

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by an appropriate Scientific Review Group convened by AHRQ in accordance
with AHRQ review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate AHRQ Office or Center. Applications
will compete for available funds with all other recommended applications submitted
in response to this FOA. The following will be considered in making funding
decisions:

Scientific merit of the proposed project as determined by peer
review

Balance of proposed approaches

Diversity of practices to be studied

Ability of results to meet the needs of diverse stakeholders

Availability of funds

Responsiveness to goals and objectives of the FOA

Relevance and fit within AHRQ portfolio priorities, as well as
overall programmatic balance

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, AHRQ
will request "Just-In-Time" information from the applicant.
Just-In-Time information generally consists of information on other support,
any additional information necessary to address administrative and budgetary issues,
and certification of IRB approval of the project's proposed use of human
subjects. For details, applicants may refer to the "AHRQ Revised
Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols
in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization for successful applications. The NoA signed by the AHRQ grants
management officer is the authorizing document and will be sent via email to
the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
These costs may be reimbursed only to the extent considered allowable
pre-award costs. See also Section IV.5., “Funding
Restrictions.”

All AHRQ grant agreement awards are subject to AHRQ’s grants
regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm),
and the terms and conditions set forth in the notice of award.

As necessary, additional Terms and Conditions will be
incorporated into the award statement.

The annual progress reports must include Sections 2.2.6 A
through F as described in the general PHS form 2590 instructions. For details
regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.
If instructions on the AHRQ website are different from the PHS form 2590
instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative
comments on both completed activities and plans for the remainder of that year,
including any changes foreseen in the future. At a minimum, the reports
will include descriptive comments on: progress to date measured against
project aims; methodological changes implemented; key preliminary findings;
significant problems and resolutions; inclusion of priority populations; and
project related publications, presentations, and dissemination
activities. AHRQ will provide the timetable for these progress reports.
In addition to the annual progress report, recipients may be required to submit
quarterly progress reports to AHRQ. Detailed instructions on reporting
requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial
Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for
ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).
AHRQ implementation of the FFR retains a financial reporting period that
coincides with the budget period of a particular project. However, the
due date for annual FFRs will be 90 days after the end of the calendar quarter
in which the budget period ends. Note that this is a change in due dates
of annual FFRs and may provide up to 60 additional days to report, depending
upon when the budget period end date falls within a calendar quarter. For
example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013
(90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and
Final Invention Statement are required when an award ends. All final reports
are due within 90 days of the project period end date. For further details
regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section
VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Recently issued AHRQ policy notices may affect your
application submission. A full list of policy notices published by AHRQ is
provided in the NIH
Guide for Grants and Contracts. Notices can also be found at: AHRQ Grants Policy Notices. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the HHS
Grants Policy Statement.

This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is
not subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under the authority of
42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74
or 92 and other referenced applicable statutes and regulations. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement. The HHS Grants
Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.